Pierre Fabre STX-241 (SILVER)

The goal of this First-In-Human (FIH) Phase I/II trial is to establish the safetyprofile, determine the Recommended Phase II Dose (RP2D), explore the pharmacokinetic (PK)exposure and pharmacodynamic (PD) properties as well as assess the efficacy of STX-241, amutant selective Central Nervous System (CNS)-penetrant fourth generation EGFR TKI, inparticipants with locally advanced or metastatic NSCLC that progressed during orfollowing third generation EGFR TKI such as osimertinib due to C797X double acquired(secondary) mutations.

{ "short_title": "Pierre Fabre STX-241 (SILVER)", "data_mode": "900", "data_mode_number": "000002384", "official_title": "Phase I/II First-In-Human Open-label Trial to Assess Safety and Efficacy of STX-241 in Participants with Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) Resistant to EGFR Tyrosine Kinase Inhibitors (TKIs).", "accrual_state": "running", "therapeutic_value": "therapeutic", "therapieansatz_value": "palliativ", "therapieintervention_value": "not_applicable", "therapielinie_value": "not_applicable", "ctgov_number": "NCT06567015", "eudract_number": "2023-510203-21", "general_contact_email": "ectu@ukdd.de", "general_contact_phone": "+49 351-4587566", "hauptpruefer_dd_name": "Prof. Dr. med. habil Martin Wermke", "description_laie_de": "Ziel dieser First-In-Human (FIH)-Studie der Phase I/II ist es, das Sicherheitsprofil zu ermitteln, die empfohlene Phase-II-Dosis (RP2D) zu bestimmen, die pharmakokinetischen (PK) und pharmakodynamischen (PD) Eigenschaften zu untersuchen sowie die Wirksamkeit von STX-241, einem mutantenselektiven EGFR-TKI der vierten Generation, bei Teilnehmern mit lokal fortgeschrittenem oder metastasiertem NSCLC, die w\u00e4hrend oder nach der Behandlung mit einem EGFR-TKI der dritten Generation wie Osimertinib aufgrund von erworbenen (sekund\u00e4ren) C797X-Doppelmutationen fortgeschritten sind.", "description_laie_en": "The goal of this First-In-Human (FIH) Phase I/II trial is to establish the safetyprofile, determine the Recommended Phase II Dose (RP2D), explore the pharmacokinetic (PK)exposure and pharmacodynamic (PD) properties as well as assess the efficacy of STX-241, amutant selective Central Nervous System (CNS)-penetrant fourth generation EGFR TKI, inparticipants with locally advanced or metastatic NSCLC that progressed during orfollowing third generation EGFR TKI such as osimertinib due to C797X double acquired(secondary) mutations.", "description_expert_de": "Ziel dieser First-In-Human (FIH)-Studie der Phase I/II ist es, das Sicherheitsprofil zu ermitteln, die empfohlene Phase-II-Dosis (RP2D) zu bestimmen, die pharmakokinetischen (PK) und pharmakodynamischen (PD) Eigenschaften zu untersuchen sowie die Wirksamkeit von STX-241, einem mutantenselektiven EGFR-TKI der vierten Generation, bei Teilnehmern mit lokal fortgeschrittenem oder metastasiertem NSCLC, die w\u00e4hrend oder nach der Behandlung mit einem EGFR-TKI der dritten Generation wie Osimertinib aufgrund von erworbenen (sekund\u00e4ren) C797X-Doppelmutationen fortgeschritten sind.", "description_expert_en": "The goal of this First-In-Human (FIH) Phase I/II trial is to establish the safetyprofile, determine the Recommended Phase II Dose (RP2D), explore the pharmacokinetic (PK)exposure and pharmacodynamic (PD) properties as well as assess the efficacy of STX-241, amutant selective Central Nervous System (CNS)-penetrant fourth generation EGFR TKI, inparticipants with locally advanced or metastatic NSCLC that progressed during orfollowing third generation EGFR TKI such as osimertinib due to C797X double acquired(secondary) mutations.", "rechtsgrundlage_value": "AMG", "phase_amg_value": "I_II", "main_cat_id": 10, "sub_cat_id": 50 }